Off-label use of drugs in neonatal intensive care units.

OBJECTIVE To estimate proportion of off-label medication use in neonates and to evaluate evidence of efficacy and safety of these medications. METHODS Chart audit in neonatal intensive care units of two institutions in Chandigarh, India. RESULTS Among 568 prescriptions in 156 neonates, 286 (50%) were off-label. Of these, 56% drugs were not approved for use in neonatal age group and 26% prescriptions were off-label for frequency, dose, indication, route or rate. Most common off-label drugs were anti-infective and antiepileptic. Despite lack of regulatory approval, one-third off-label drugs had level I-II evidence of safety and efficacy for use in neonates. CONCLUSION Use of off-label drugs is common in sick neonates.